100NX EXPRESS Upgrade Kit with VELOCITY 10134V

GUDID 10705037068166

100NX EXPRESS Upgrade Kit with VELOCITY

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Plasma sterilizer
Primary Device ID10705037068166
NIH Device Record Key65c581a6-1900-4b9a-b31e-4615aca85abc
Commercial Distribution StatusIn Commercial Distribution
Brand Name100NX EXPRESS Upgrade Kit with VELOCITY
Version Model Number10134V
Catalog Number10134V
Company DUNS947451626
Company NameADVANCED STERILIZATION PRODUCTS SERVICES INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.

Device Identifiers

Device Issuing AgencyDevice ID
GS110705037068166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MLRSterilizer, chemical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-27
Device Publish Date2021-07-19

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